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ACTIVE NOT RECRUITING

NCT07112352

PHASE2

Healthy Ageing: a Feasibility Study to Evaluate Digitally-enabled Ways to Support Healthy Ageing

Sponsor: Imperial College London

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if it is feasibility to conduct a trial of two digitally-enabled interventions that support older adults to adopt healthy behaviours. It will also learn about the safety of this digital intervention. The main questions it aims to answer are * How acceptable and feasible are the trial, intervention and control groups in assessing outcomes * What is the estimated effect of the interventions? Researchers will compare Smart devices with a bespoke 'Healthy Habits' application and three healthy habit coaching and data feedback modules, to a group with smart devices and standard off-the-shelf feedback application, to a control group that will receive an education leaflet to adopt healthy behaviours. Participants will: * Use sensors and the 'Healthy Habits' application for 3 months followed by standard application for 3 months, or sensors and standard application for 6 months, or control * Either home visit or in-centre visit once every 3 months for assessments and online health questionnaires * Complete daily diary of any healthcare use

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-07-28

Completion Date

2026-04

Last Updated

2026-03-25

Healthy Volunteers

Conditions

Frailty Older Adults (65 Years and Older)Digital Health Intervention Feasibility Studies

Interventions

COMBINATION_PRODUCT

Smart devices with Personalised data feedback and habit coaching

Smart devices (smartwatch and sleep mat) with a bespoke 'Healthy Habits' application with three healthy habit coaching and data feedback modules, focused on active minutes, steps and sedentary time, viewable on a tablet.

DEVICE

Smart devices with data feedback

Smart devices (smartwatch and sleep mat) with a standard off-the-shelf data feedback application ("WithingsTM App") providing generalised data feedback from the participant's smartwatch and sleep mat, viewable on a tablet for 6 months.

OTHER

Control

Standard care where they will be signposted to National Health Service (NHS) guidance on Healthy Ageing for older adults.

Inclusion Criteria: * • Older adults (age ≥65) * Community-dwelling Adults living at home * Living within the London boroughs * Willing to engage in an exercise programme * On at least one medication * Pre-frail on Edmonton-AC and/or FRAIL and PRISMA \< 3 * Clinically assessed to have Fried 1-3 (this is completed at baseline assessment) * Has the capacity to provide informed consent * Able to speak and understand written English Exclusion Criteria: * • Adults less than 65 years old * Living outside the London boroughs * Living in a nursing home or hospitalised or hospice * Not taking any medication (indicating robust frailty status) * Significant cognitive impairment due to concerns that cognitive impairment and its causes presents different barriers to engagement and participation with sensors and intervention * Individuals with severe limitations in activities of daily living which would prevent active participation in the assessments, interfere with participation in the physical exercise programme * Being unable to safely engage in the exercise component for other health-related reasons such as Musculoskeletal or neurological disorders that impair gait speed and balance as these are key outcome metrics * Progressive or severe medical illness e.g. acute myocardial infarction in the last 3 months, unstable angina, severe aortic stenosis, uncontrolled orthostatic hypotension, recent bone fracture in the last 3 months, having a life expectancy of less than 24 months, requiring palliative care within the following two years, three or more hospitalisations in the last year * Moderate - Severe Depression, Psychiatric disorders which may interfere with their participation in the study * Being treated for active cancer * Unstable medical conditions or where clinical optimisation required e.g. uncontrolled diabetes. * Participating in other clinical studies * Unable to participate for 6 months in the study (with 28 days allowed to be away from home) * Unable to speak or understand written English

Locations (1)

Helix Centre, Institute of Global Health Innovation, Department of Surgery and Cancer, Imperial College London

London, United Kingdom